Mitigating single point failure of devices in an analyte monitoring system and methods thereof

ABSTRACT

Methods, devices, and kits are provided for mitigating single point failure of at least one device in an analyte monitoring system.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/016,247, now U.S. Pat. No. 9,743,872, which is acontinuation of U.S. patent application Ser. No. 14/251,542 filed Apr.11, 2014, now U.S. Pat. No. 9,289,179, which is a continuation of U.S.patent application Ser. No. 13/684,078 filed Nov. 21, 2012, now U.S.Pat. No. 8,710,993, which claims priority to U.S. ProvisionalApplication No. 61/563,518, filed Nov. 23, 2011, entitled “MitigatingSingle Point Failure of Devices in an Analyte Monitoring System andMethods Thereof”, the disclosures of each of which are incorporatedherein by reference in their entirety for all purposes.

BACKGROUND

The detection of the level of glucose or other analytes, such aslactate, oxygen or the like, in certain individuals is vitally importantto their health. For example, the monitoring of glucose is particularlyimportant to individuals with diabetes. Diabetics may need to monitorglucose levels to determine when insulin is needed to reduce glucoselevels in their bodies or when additional glucose is needed to raise thelevel of glucose in their bodies.

Devices have been developed for continuous or automatic monitoring ofanalytes, such as glucose, in bodily fluid such as in the blood streamor in interstitial fluid. Some of these analyte measuring devices areconfigured so that at least a portion of the devices are positionedbelow a skin surface of a user, e.g., in a blood vessel or in thesubcutaneous tissue of a user.

SUMMARY

Embodiments of the present disclosure include methods for mitigatingsingle point failure of at least one device in an analyte monitoringsystem. Certain aspects include requesting that a functionality check ofone or more components of a first device be performed and that datarelated to the functionality check of the one or more components of thefirst device be communicated to a second device, receiving, informationfrom the first device that is related to functionality of the one ormore components of the first device, communicating the informationrelated to the functionality of the one or more components of the firstdevice to a third device, receiving a request from the third device thatan alarm be annunciated if it is determined by the third device that theone or more components of the first device is not functioning inaccordance with at least one predetermined criterion and annunciating analarm to alert a user that the one or more components of the firstdevice is not functioning in accordance with the at least onepredetermined criterion.

Embodiments of the present disclosure include computer-implementedmethods for mitigating single point failure of at least one device in ananalyte monitoring. Certain aspects include requesting that afunctionality check of one or more components of a first device beperformed and that data related to the functionality check of the one ormore components of the first device be communicated to a second device,receiving the data related to the functionality of the one or morecomponents of the first device, retrieving a list including at least onepredetermined criterion related to the functionality of the one or morecomponents of the first device from a storage component of the seconddevice, comparing the data related to the functionality of the one ormore components of the first device with the list including the at leastone predetermined criterion and determining if the one or morecomponents of the first device is functioning in accordance with the atleast one predetermined criterion.

Embodiments of the present disclosure include computer-implementedmethods for mitigating single point failure of at least one device in ananalyte monitoring. Certain aspects include requesting that afunctionality check of one or more components of a first device beperformed and that data related to the functionality check of the one ormore components of the first device be communicated to a second deviceand determining that the one or more components of the first device isnot functioning properly if the data related to the functionality checkof the components of the first device is not received at the seconddevice, wherein an alarm is annunciated from at least one of the seconddevice or a third device to alert a user that one or more components ofthe first device is not functioning properly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a data monitoring and management system such as, forexample, an analyte (e.g., glucose) monitoring system in accordance withcertain embodiments of the present disclosure;

FIG. 2 illustrates a data monitoring and management system for real timeglucose measurement data acquisition and processing in one aspect of thepresent disclosure;

FIG. 3 is a block diagram of a receiver/monitor unit such as that shownin FIG. 1 in accordance with certain embodiments;

FIG. 4 is a flowchart illustrating a method for mitigating single pointfailure of at least one device in an analyte monitoring system inaccordance with certain embodiments of the present disclosure;

FIG. 5 is a flowchart illustrating a method for mitigating single pointfailure of at least one device in an analyte monitoring system inaccordance with certain embodiments of the present disclosure;

FIG. 6 is a flowchart illustrating a method for mitigating single pointfailure of at least one device in an analyte monitoring system inaccordance with certain embodiments of the present disclosure; and

FIG. 7 is a flowchart illustrating a method for mitigating single pointfailure of at least one device in an analyte monitoring system inaccordance with certain embodiments of the present disclosure.

DETAILED DESCRIPTION

Before the present disclosure is further described, it is to beunderstood that this disclosure is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present disclosure will be limited only by the appendedclaims.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges, and are also encompassed within the disclosure, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present disclosure, exemplarymethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural referents unless the context clearly dictatesotherwise. It is further noted that the claims may be drafted to excludeany optional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

FIG. 1 shows a data monitoring and management system such as, forexample, an analyte (e.g., glucose) monitoring system in accordance withcertain embodiments of the present disclosure. Embodiments of thesubject disclosure are described primarily with respect to glucosemonitoring devices and systems, and methods of using two or more devicesin a glucose monitoring system to reduce the likelihood of a failure ofone or more of the devices in the glucose monitoring system goingunnoticed by a user.

Analytes that may be monitored include, but are not limited to, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin,creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose,glutamine, growth hormones, hormones, ketones, lactate, peroxide,prostate-specific antigen, prothrombin, RNA, thyroid stimulatinghormone, and troponin. The concentration of drugs, such as, for example,antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin,digoxin, drugs of abuse, theophylline, and warfarin, may also bemonitored. In those embodiments that monitor more than one analyte, theanalytes may be monitored at the same or different times.

Referring to FIG. 1, the analyte monitoring system 100 includes a sensor101, a data processing unit (e.g., sensor electronics) 102 connectableto the sensor 101, and a primary receiver unit 104 which is configuredto communicate with the data processing unit 102 via a communicationlink 103. In aspects of the present disclosure, the sensor 101 and thedata processing unit (sensor electronics) 102 may be configured as asingle integrated assembly 110. In certain embodiments, the integratedsensor and sensor electronics assembly 110 may be configured as anon-body patch device. In such embodiments, the on-body patch device maybe configured for, for example, RFID or RF communication with a readerdevice/receiver unit, and/or an insulin pump.

In certain embodiments, the primary receiver unit 104 may be furtherconfigured to transmit data to a data processing terminal 105 toevaluate or otherwise process or format data received by the primaryreceiver unit 104. The data processing terminal 105 may be configured toreceive data directly from the data processing unit 102 via acommunication link which may optionally be configured for bi-directionalcommunication. Further, the data processing unit 102 may include atransmitter or a transceiver to transmit and/or receive data to and/orfrom the primary receiver unit 104, the data processing terminal 105 oroptionally the secondary receiver unit 106.

Also shown in FIG. 1 is an optional secondary receiver unit 106 which isoperatively coupled to the communication link and configured to receivedata transmitted from the data processing unit 102. The secondaryreceiver unit 106 may be configured to communicate with the primaryreceiver unit 104, as well as the data processing terminal 105. Thesecondary receiver unit 106 may be configured for bi-directionalwireless communication with each of the primary receiver unit 104 andthe data processing terminal 105. As discussed in further detail below,in certain embodiments the secondary receiver unit 106 may be ade-featured receiver as compared to the primary receiver unit 104, i.e.,the secondary receiver unit 106 may include a limited or minimal numberof functions and features as compared with the primary receiver unit104. As such, the secondary receiver unit 106 may include a smaller (inone or more, including all, dimensions), compact housing or embodied ina device such as a wrist watch, arm band, etc., for example.Alternatively, the secondary receiver unit 106 may be configured withthe same or substantially similar functions and features as the primaryreceiver unit 104. The secondary receiver unit 106 may include a dockingportion to be mated with a docking cradle unit for placement by, e.g.,the bedside for night time monitoring, and/or bi-directionalcommunication device.

Only one sensor 101, data processing unit 102 and data processingterminal 105 are shown in the embodiment of the analyte monitoringsystem 100 illustrated in FIG. 1. However, it will be appreciated by oneof ordinary skill in the art that the analyte monitoring system 100 mayinclude more than one sensor 101 and/or more than one data processingunit 102, and/or more than one data processing terminal 105.

The analyte monitoring system 100 may be a continuous monitoring system,or semi-continuous, or a discrete monitoring system. In amulti-component environment, each component may be configured to beuniquely identified by one or more of the other components in the systemso that communication conflict may be readily resolved between thevarious components within the analyte monitoring system 100. Forexample, unique IDs, communication channels, and the like, may be used.

In certain embodiments, the sensor 101 is physically positioned in or onthe body of a user whose analyte level is being monitored. The sensor101 may be configured to at least periodically perform a functionalitycheck and convert the results of the functionality check into acorresponding signal for transmission by the data processing unit 102.

The data processing unit 102 is coupleable to the sensor 101 so thatboth devices are positioned in or on the user's body, with at least aportion of the analyte sensor 101 positioned transcutaneously. The dataprocessing unit 102 in certain embodiments may include a portion of thesensor 101 (proximal section of the sensor in electrical communicationwith the data processing unit 102) which is encapsulated within or onthe printed circuit board of the data processing unit 102 with, forexample, potting material or other protective material. The dataprocessing unit 102 performs data processing functions, where suchfunctions may include but are not limited to, filtering and encoding ofdata signals, each of which corresponds to a sampled analyte level ofthe user, for transmission to the primary receiver unit 104 via thecommunication link 103. In one embodiment, the sensor 101 or the dataprocessing unit 102 or a combined sensor/data processing unit may bewholly implantable under the skin layer of the user.

In one aspect, the primary receiver unit 104 may include an analoginterface section including an RF receiver and an antenna that isconfigured to communicate with the data processing unit 102 via thecommunication link 103, and a data processing section for processing thereceived data from the data processing unit 102 such as data decoding,error detection and correction, data clock generation, and/or data bitrecovery.

In operation, the primary receiver unit 104 in certain embodiments isconfigured to synchronize with the data processing unit 102 to uniquelyidentify the data processing unit 102, based on, for example, anidentification information of the data processing unit 102, andthereafter, to periodically receive signals transmitted from the dataprocessing unit 102 associated with the monitored analyte levelsdetected by the sensor 101. That is, when operating in the CGM mode, thereceiver unit 104 in certain embodiments is configured to automaticallyreceive data related to the functionality of the sensor from the analytesensor/sensor electronics when the communication link (e.g., RF range)is maintained between these components.

Referring again to FIG. 1, the data processing terminal 105 may includea personal computer, a portable data processing devices or computerssuch as a laptop computer or a handheld device (e.g., personal digitalassistants (PDAs), communication devices such as a cellular phone (e.g.,a multimedia and Internet-enabled mobile phone such as an iPhone, aBlackberry device, a Palm device such as Palm Pre, Treo, or similarphone), mp3 player, pager, and the like), drug delivery device, insulinpump, each of which may be configured for data communication with thereceiver via a wired or a wireless connection. Additionally, the dataprocessing terminal 105 may further be connected to a data network (notshown).

The data processing terminal 105 may include an infusion device such asan insulin infusion pump or the like, which may be configured toadminister insulin to patients, and which may be configured tocommunicate with the primary receiver unit 104 for receiving, amongothers, the measured analyte level. Alternatively, the primary receiverunit 104 may be configured to integrate an infusion device therein sothat the primary receiver unit 104 is configured to administer insulin(or other appropriate drug) therapy to patients, for example, foradministering and modifying basal profiles, as well as for determiningappropriate boluses for administration based on, among others, thedetected analyte levels received from the data processing unit 102. Aninfusion device may be an external device or an internal device (whollyimplantable in a user).

In particular embodiments, the data processing terminal 105, which mayinclude an insulin pump, may be configured to receive the functionalitysignals from the data processing unit 102, and thus, incorporate thefunctions of the primary receiver unit 104 including data processing formanaging the patient's insulin therapy and analyte monitoring. Incertain embodiments, the communication link 103 as well as one or moreof the other communication interfaces shown in FIG. 1 may use one ormore of an RF communication protocol, an infrared communicationprotocol, a Bluetooth® enabled communication protocol, an 802.11xwireless communication protocol, or an equivalent wireless communicationprotocol which would allow secure, wireless communication of severalunits (for example, per HIPAA requirements) while avoiding potentialdata collision and interference.

As described in aspects of the present disclosure, the analytemonitoring system may include an on-body patch device with a thinprofile that can be worn on the arm or other locations on the body (andunder clothing worn by the user or the patient), the on-body patchdevice including an analyte sensor and circuitry and components foroperating the sensor and processing and storing signals, includingfunctionality signals, received from the sensor as well as forcommunication with the reader device. For example, one aspect of theon-body patch device may include electronics to sample the voltagesignal received from the analyte sensor in fluid contact with the bodyfluid, and to process the sampled voltage signals into the correspondingglucose values and/or store the sampled voltage signal as raw data, orto perform a functionality check of its components, and to process theresults of the functionality check into a signal or data.

In certain embodiments, the on-body patch device includes an antennasuch as a loop antenna to receive RF power from an external device suchas the reader device/receiver unit described above, electronics toconvert the RF power received via the antenna into DC (direct current)power for the on-body patch device circuitry, communication module orelectronics to detect commands received from the reader device, andcommunication component to transmit data to the reader device, a lowcapacity battery for providing power to sensor sampling circuitry (forexample, the analog front end circuitry of the on-body patch device insignal communication with the analyte sensor), one or more non-volatilememory or storage device to store data including raw signals from thesensor or processed data based on the raw sensor signals. Morespecifically, in the on operation demand mode, the on-body patch devicein certain embodiments is configured to transmit real time analyterelated data and/or stored historical analyte related data, and/orfunctionality data when within the RF power range of the reader device.As such, when the reader device is removed or positioned out of rangerelative to the on-body patch device, the on-body patch device may nolonger transmit the analyte related data and/or functionality data.

In certain embodiments, a data processing module/terminal may beprovided in the analyte monitoring system that is configured to operateas a data logger, interacting or communicating with the on-body patchdevice by, for example, transmitting requests for functionalityinformation to the on-body patch device, and storing the responsivefunctionality information received from the on-body patch device in oneor more memory components of the data processing module (e.g., repeaterunit). Further, data processing module may be configured as a compacton-body relay device to relay or retransmit the received analyte levelinformation from the on-body patch device to the reader device/receiverunit or the remote terminal or both. The data processing module in oneaspect may be physically coupled to the on-body patch device, forexample, on a single adhesive patch on the skin surface of the patient.Alternatively, the data processing module may be positioned close to butnot in contact with the on-body patch device. For example, when theon-body patch device is positioned on the abdomen of the patient, thedata processing module may be worn on a belt of the patient or the user,such that the desired close proximity or predetermined distance ofapproximately 1-5 inches (or about 1-10 inches, for example, or more)between the on-body patch device and the data processing module may bemaintained.

The various processes described above including the processes operatingin the software application execution environment in the analytemonitoring system including the on-body patch device, the reader device,data processing module and/or the remote terminal performing one or moreroutines described above may be embodied as computer programs developedusing an object oriented language that allows the modeling of complexsystems with modular objects to create abstractions that arerepresentative of real world, physical objects and theirinterrelationships. The software required to carry out the inventiveprocess, which may be stored in a memory or storage device of thestorage unit of the various components of the analyte monitoring systemdescribed above in conjunction to the Figures including the on-bodypatch device, the reader device, the data processing module, variousdescribed communication devices, or the remote terminal may be developedby a person of ordinary skill in the art and may include one or morecomputer program products.

In one embodiment, an apparatus for bi-directional communication with ananalyte monitoring system may comprise a storage device having storedtherein one or more routines, a processing unit operatively coupled tothe storage device and configured to retrieve the stored one or moreroutines for execution, a data transmission component operativelycoupled to the processing unit and configured to transmit data based atleast in part on the one or more routines executed by the processingunit, and a data reception component operatively coupled to theprocessing unit and configured to receive functionality related datafrom a remote location and to store the received functionality relateddata in the storage device for retransmission, wherein the datatransmission component is programmed to transmit a query to a remotelocation, and further wherein the data reception component receives thefunctionality related data from the remote location in response to thetransmitted query when one or more electronics in the remote locationtransitions from an inactive state to an active state upon detection ofthe query from the data transmission component.

FIG. 2 illustrates a data monitoring and management system forfunctionality related data acquisition and processing in one aspect ofthe present disclosure. More specifically, as shown in FIG. 2, theon-body patch device 211 including sensor electronics coupled to ananalyte sensor 250 is positioned on a skin surface 210 of a patient or auser.

Referring back to FIG. 2, as shown, when the reader device/receiver unit220 is positioned or placed in close proximity and within apredetermined range of the on-body patch device 211, the RF power supplyin the reader device/receiver unit 220 may be configured to provide thenecessary power to operate the electronics in the on-body patch device211, and the on-body patch device 211 may be configured to, upondetection of the RF power from the reader device/receiver unit 220,perform preprogrammed routines including, for example, transmitting oneor more signals 240 to the reader device/receiver unit 220 indicative ofthe functionality of the components of the analyte sensor 250, orperforming functionality check of one or more components of the analytesensor 250.

In certain embodiments, the reader device/receiver unit 220 may includean RF power switch that is user activatable or activated uponpositioning within a predetermined distance from the on-body patchdevice 211 to turn on the analyte sensor in the on-body patch device211. That is, using the RF signal, the analyte sensor coupled to thesensor electronics in the on-body patch device 211 may be initialized oractivated. In another embodiment, a passive RFID function may beprovided or programmed such that upon receiving a “turn on” signalwhich, when authenticated, will turn on the electronic power switch thatactivates the on-body patch device 211. That is, the passive RFIDconfiguration may include drawing energy from the RF field radiated fromthe reader device/receiver unit 220 so as to prompt for and/or detectthe “turn on” signal which, upon authentication, activates the on-bodypatch device 211.

In one embodiment, communication and/or RF power transfer between thereader device/receiver unit 220 and the on-body patch device 211 may beautomatically initiated when the reader device/receiver unit 220 isplaced in close proximity to the on-body patch device 211 as discussedabove. Alternatively, the reader device/receiver unit 220 may beconfigured such that user activation, such as data request initiationand subsequent confirmation by the user using, for example, the display222 and/or input components 221 of the reader device/receiver unit 220,may be required prior to the initiation of communication and/or RF powertransfer between the reader device/receiver unit 220 and the on-bodypatch device 211. In a further embodiment, the reader device/receiverunit 220 may be user configurable between multiple modes, such that theuser may choose whether the communication between the readerdevice/receiver unit 220 and on-body patch device 211 is performedautomatically or requires a user activation and/or confirmation.

As further shown in FIG. 2, the display 222 of the readerdevice/receiver unit 220 may be configured to provide thefunctionalities of a user interface to present information such as alarmor alert notification to the user. In one aspect, the readerdevice/receiver unit 220 may include other output components such as aspeaker, vibratory output component and the like to provide audibleand/or vibratory output indication to the user in addition to the visualoutput indication provided on the display 222.

As discussed, some or all of the electronics in the on-body patch device211 in one embodiment may be configured to rely on the RF power receivedfrom the reader device/receiver unit 220 to perform functionality dataprocessing and/or transmission of the processed functionalityinformation to the reader device/receiver unit 220. That is, the on-bodypatch device 211 may be discreetly worn on the body of the user or thepatient, and under clothing, for example, and when desired, bypositioning the reader device/receiver unit 220 within a predetermineddistance from the on-body patch device 211, functionality informationmay be received by the reader device/receiver unit 220.

Referring still to FIG. 2, also shown are a data processingmodule/terminal 260 and a remote terminal 270. In one aspect, dataprocessing module 260 may include a stand alone device configured forbi-directional communication to communicate with the on-body patchdevice 211, the reader device/receiver unit 220 and/or the remoteterminal 270. More specifically, data processing module 260 may includeone or more microprocessors or similar data processing componentsconfigured to execute one or more software routines for communication,as well as data storage and retrieval to and from one or more memorycomponents provided in the housing of the data processing module 260.

The data processing module 260 in one embodiment may be configured tocommunicate with the on-body patch device 211 in a similar manner as thereader device/receiver unit 220 and may include communication componentssuch as antenna, power supply and memory, among others, for example, toallow provision of RF power to the on-body patch device 211 or torequest or prompt the on-body patch device 211 to send the functionalityrelated data and optionally stored analyte related data. The dataprocessing module 260 may be configured to interact with the on-bodypatch device 211 in a similar manner as the reader device/receiver unit220 such that the data processing module 260 may be positioned within apredetermined distance from the on-body patch device 211 forcommunication with the on-body patch device 211.

In one aspect, the on-body patch device 211 and the data processingmodule 260 may be positioned on the skin surface of the user or thepatient within the predetermined distance of each other (for example,within approximately 5 inches or less) such that the communicationbetween the on-body patch device 211 and the data processing module 260is maintained. In a further aspect, the housing of the data processingmodule 260 may be configured to couple to or cooperate with the housingof the on-body patch device 211 such that the two devices are combinedor integrated as a single assembly and positioned on the skin surface.

Referring again to FIG. 2, the data processing module 260 may beconfigured or programmed to prompt or ping the on-body patch device 211at a predetermined time interval such as once every minute, or onceevery five minutes or once every 30 minutes or any other suitable ordesired programmable time interval to request functionality related datafrom the on-body patch device 211 which is received and is stored in oneor more memory devices or components of the data processing module 260.In another embodiment, the data processing module 260 is configured toprompt or ping the on-body patch device 211 when desired by the patientor the user on-demand, and not based on a predetermined time interval.In yet another embodiment, the data processing module 260 is configuredto prompt or ping the on-body patch device 211 when desired by thepatient or the user upon request only after a programmable time intervalhas elapsed. For example, in certain embodiments, if the user does notinitiate communication within a programmed time period, such as, forexample 5 hours from last communication (or 10 hours from the lastcommunication), the data processing module 260 may be programmed toautomatically ping or prompt the on-body patch device 211 oralternatively, initiate an alarm function to notify the user that anextended period of time has elapsed since the last communication betweenthe data processing module 260 and the on-body patch device 211. In thismanner, users, healthcare providers, or the patient may program orconfigure the data processing module 260 to provide certain compliancewith analyte monitoring regimen, to avoid a failure of the analytesensor device from going unnoticed. Similar functionalities may beprovided or programmed in the receiver unit or the reader device incertain embodiments.

As further shown in FIG. 2, the data processing module 260 in one aspectmay be configured to transmit the stored data received from the on-bodypatch device 211 to the reader device/receiver unit 220 whencommunication between the data processing module 260 and the readerdevice/receiver unit 220 is established. More specifically, in additionto RF antenna and RF communication components described above, dataprocessing module 260 may include components to communicate using one ormore wireless communication protocols such as, for example, but notlimited to, infrared (IR) protocol, Bluetooth® protocol, Zigbee®protocol, and 802.11 wireless LAN protocol. Additional description ofcommunication protocols including those based on Bluetooth® protocoland/or Zigbee® protocol can be found in U.S. Patent Publication No.2006/0193375 incorporated herein by reference for all purposes. The dataprocessing module 260 may further include communication ports, driversor connectors to establish wired communication with one or more of thereader device/receiver unit 220, on-body patch device 211, or the remoteterminal 270 including, for example, but not limited to USB connectorand/or USB port, Ethernet connector and/or port, FireWire connectorand/or port, or RS-232 port and/or connector.

In one aspect, the data processing module 260 may be configured tooperate as a data logger configured or programmed to periodicallyrequest or prompt the on-body patch device 211 to transmit thefunctionality related information, and to store the received informationfor later retrieval or subsequent transmission to the readerdevice/receiver unit 220 or to the remote terminal 270 or both, forfurther processing and analysis.

In a further aspect, the functionalities of the data processing module260 may be configured or incorporated into a memory device such as an SDcard, microSD card, compact flash card, XD card, Memory Stick card,Memory Stick Duo card, or USB memory stick/device including softwareprogramming resident in such devices to execute upon connection to therespective one or more of the on-body patch device 211, the remoteterminal 270 or the reader device/receiver unit 220. In a furtheraspect, the functionalities of the data processing module 260, includingexecutable software and programming, may be provided to a communicationdevice such as a mobile telephone including, for example, iPhone, iPodTouch, Blackberry device, Palm based device (such as Palm Pre, Treo,Treo Pro, Centro), personal digital assistants (PDAs) or any othercommunication enabled operating system (such as Windows or Androidoperating systems) based mobile telephones as a downloadable applicationfor execution by the downloading communication device. To this end, theremote terminal 270 as shown in FIG. 2 may include a personal computer,or a server terminal that is configured to provide the executableapplication software to one or more of the communication devicesdescribed above when communication between the remote terminal 270 andthe devices are established.

Depending upon the user setting or configuration on the communicationdevice, the downloaded application may be programmed or customized usingthe user interface of the respective communication device (screen,keypad, and the like) to establish or program the desired settings suchas a receiver alarm, an insulin pump alarm, sensor replacement alarm, orany other alarm or alert conditions as may be desired by the user.Moreover, the programmed notification settings on the communicationdevice may be output using the output components of the respectivecommunication devices, such as speaker, vibratory output component, orvisual output/display. As a further example, the communication devicemay be provided with programming and application software to communicatewith the on-body patch device 211 such that a frequency or periodicityof data acquisition is established. In this manner, the communicationdevice may be configured to conveniently receive functionalityinformation from the on-body patch device 211 at predetermined timeperiods such as, for example, but not limited to once every minute, onceevery five minutes, or once every 10 or 15 minutes, and store thereceived information, as well as to provide a desired or appropriatewarning indication or notification to the user or the patient.

FIG. 3 is a block diagram of a receiver/monitor unit or insulin pumpsuch as that shown in FIG. 1 in accordance with certain embodiments. Theprimary receiver unit 104 (FIG. 1) includes one or more of: a bloodglucose test strip interface 301, an RF receiver 302, an input 303, atemperature detection section 304, and a clock 305, each of which isoperatively coupled to a processing and storage section 307. The primaryreceiver unit 104 also includes a power supply 306 operatively coupledto a power conversion and monitoring section 308. Further, the powerconversion and monitoring section 308 is also coupled to the receiverprocessor 307. Moreover, also shown are a receiver serial communicationsection 309, and an output 310, each operatively coupled to theprocessing and storage unit 307. The receiver may include user inputand/or interface components or may be free of user input and/orinterface components.

In one aspect, the RF receiver 302 is configured to communicate, via thecommunication link 103 (FIG. 1) with the data processing unit (sensorelectronics) 102, to receive encoded data from the data processing unit102 for, among others, signal mixing, demodulation, and other dataprocessing. The input 303 of the primary receiver unit 104 is configuredto allow the user to enter information into the primary receiver unit104 as needed. In one aspect, the input 303 may include keys of akeypad, a touch-sensitive screen, and/or a voice-activated input commandunit, and the like. The temperature monitor section 304 may beconfigured to provide temperature information of the primary receiverunit 104 to the processing and control section 307, while the clock 305provides, among others, real time or clock information to the processingand storage section 307.

Each of the various components of the primary receiver unit 104 shown inFIG. 3 is powered by the power supply 306 (or other power supply) which,in certain embodiments, includes a battery. Furthermore, the powerconversion and monitoring section 308 is configured to monitor the powerusage by the various components in the primary receiver unit 104 foreffective power management and may alert the user, for example, in theevent of power usage which renders the primary receiver unit 104 insub-optimal operating conditions. The serial communication section 309in the primary receiver unit 104 is configured to provide abi-directional communication path from the testing and/or manufacturingequipment for, among others, initialization, testing, and configurationof the primary receiver unit 104.

Serial communication section 309 can also be used to upload data to acomputer, such as functionality related data. The communication linkwith an external device (not shown) can be made, for example, by cable(such as USB or serial cable), infrared (IR) or RF link. Theoutput/display 310 of the primary receiver unit 104 is configured toprovide, among others, a graphical user interface (GUI), and may includea liquid crystal display (LCD) for displaying information. Additionally,the output/display 310 may also include an integrated speaker foroutputting audible signals as well as to provide vibration output ascommonly found in handheld electronic devices, such as mobiletelephones, pagers, etc. In certain embodiments, the primary receiverunit 104 also includes an electro-luminescent lamp configured to providebacklighting to the output 310 for output visual display in dark ambientsurroundings.

Referring back to FIG. 3, the primary receiver unit 104 may also includea storage section such as a programmable, non-volatile memory device aspart of the processor 307, or provided separately in the primaryreceiver unit 104, operatively coupled to the processor 307. Theprocessor 307 may be configured to perform Manchester decoding (or otherprotocol(s)) as well as error detection and correction upon the encodeddata received from the data processing unit 102 via the communicationlink 103.

In further embodiments, the data processing unit 102 and/or the primaryreceiver unit 104 and/or the secondary receiver unit 106, and/or thedata processing terminal/infusion section 105 of FIG. 1 may beconfigured to receive the blood glucose value wirelessly over acommunication link from, for example, a blood glucose meter. In furtherembodiments, a user manipulating or using the analyte monitoring system100 (FIG. 1) may manually input the blood glucose value using, forexample, a user interface (for example, a keyboard, keypad, voicecommands, and the like) incorporated in the one or more of the dataprocessing unit 102, the primary receiver unit 104, secondary receiverunit 106, or the data processing terminal/infusion section 105.

Additional detailed descriptions are provided in U.S. Pat. Nos.5,262,035; 5,264,104; 5,262,305; 5,320,715; 5,593,852; 6,175,752;6,650,471; 6,746,582; 6,284,478; 7,299,082; and 7,811,231; in U.S.application Ser. No. 11/060,365 filed Feb. 16, 2005 titled “Method andSystem for Providing Data Communication in Continuous Glucose MonitoringAnd Management System”, now U.S. Pat. No. 8,771,183, in U.S. applicationSer. No. 12/698,124 filed Feb. 1, 2010 titled “Compact On-BodyPhysiological Monitoring Devices and Methods Thereof”, and in U.S.application Ser. No. 12/807,278 filed Aug. 31, 2010 titled “MedicalDevices and Methods”, each of which is incorporated herein by reference.

A safety issue with the receiver device, continuous glucose monitors(CGMs), repeater unit, and insulin pumps in an analyte monitoring systemis the susceptibility to single point failure associated with eachdevice's microprocessor, power supply, audio annunciators, transmitter,and transceiver. Introducing a power supply monitoring circuit, amicroprocessor monitoring circuit, a secondary power supply, and/oraudio annunciator (or vibrator) to the device will provide redundancythat will reduce the likelihood of a failure going unnoticed by theuser; however, including these components is costly in terms of expenseand product size. The embodiments of the present disclosure provideadditional protection against single point failures in systems made upof two or more devices. Essentially, each device in the analytemonitoring system is monitored by one or more of the other devices inthe system.

In certain integrated CGM and insulin pump system embodiments, whereboth devices contain at least one microprocessor, power supply, andaudio annunciator or other alarm mechanism, in one embodiment, eachdevice can perform a periodic self test and report this to the otherdevice. Each device has a monitoring process that would initiate analarm if the other device does not report a successful self test. Insome embodiments, the monitoring device could poll the other device, andeven initiate the self test on the other device. Also, differentfunctionality could be tested and/or reported on different testschedules.

The applicability of this functionality depends on how necessaryperiodic communication between the devices is to the function of thesystem. For instance, in certain embodiments where the receiver deviceof a continuous analyte monitoring system may not need to be incommunication, such as RF communication, range with an insulin pump forthe insulin pump to function, this feature could be optional, e.g.,configured by the user, a parent of the user, and/or a physician. Inother embodiments, such as for a closed loop control system where thecontrol algorithm is maintained in the receiver device, frequentcommunication is needed between the handheld and the pump, and thereforecontinuous knowledge of the functionality of both devices is vital.

FIG. 4 is a flow diagram illustrating steps in an embodiment formitigating single point failure of at least one device in an analytemonitoring system 400. The first device 402 and the second device 404 inthe analyte monitoring system 400 can be at least one of a receiverdevice, an analyte meter, a glucose monitor, an insulin pump, acontinuous analyte monitor, a cellular phone, a personal digitalassistant, a personal computer, a laptop computer, and/or a repeaterunit. In certain embodiments, a first device 402 sends a request that afunctionality check of the components of a second device 404 beperformed (406). The request can be sent, for example, wirelessly fromthe transmitter of the first device 402 to the transceiver of the seconddevice 404. The components of the second device 404 can include at leastone of a microprocessor, a power supply, a sensor, an electroniccomponent, and a storage device.

The second device 404 receives the request to perform a functionalitycheck of the second device 404 from the first device 402 (408) andperforms the functionality check of its components (410). In certainembodiments, the second device 404 only performs the functionality checkif the second device 404 has the capacity to perform the check. Afunctionality check, or “self-test”, is a standard feature of mostelectronic devices. The functionality check of the components caninclude a determination of the current, voltage, and/or resistance thatcan be measured across an electrical circuit in the one or morecomponents. The functionality check can include component testing thatapplies an input to the various components being tested, and receives anoutput based on the input. The functionality check may also includechecking digital system components, such as a checksum for a block ofmemory. Any of a number of common techniques used in electronic devicescan be applied to the functionality check of the present disclosure. Inaddition, some components of the devices in the analyte monitoringsystem may have built in self-test functionality that can be queried.For instance, a power supply module may have a digital self-test statusoutput that can be queried by the processor in order to determine thefunctionality of the power supply. A device may have electroniccircuitry that includes electronic or mechanical switches that allowtesting of the electronic circuitry. The switch, for example, couldroute the current path for functional test across the speaker circuit totest for the proper speaker resistance, in order to detect any open orshort circuits.

Referring still to FIG. 4, the second device 404 determines thefunctionality of its components based on the outcome of thefunctionality check (412) and the second device 404 communicates datarelated to the determined functionality of its components to the firstdevice 402 (414). In certain embodiments the second device 404determining the functionality of its components (412) is optional anddata related to the functionality of the second device 404 can be sentto the first device 402 without a determination of functionality beingprocessed at the second device 404. The data can be communicated, forexample, from the transmitter of the second device 404 to thetransceiver of the first device 402.

Still referring to FIG. 4, the data related to the functionality of thecomponents of the second device 404 is received at the first device 402(416). The first device 402 then retrieves from storage a list thatincludes at least one predetermined criterion related to thefunctionality of the components of the second device 404 (418). Thepredetermined criterion can be, for instance, current, voltage and/orresistance thresholds or ranges used to define the proper operatingrange. In certain embodiments, for example, the functional check maymeasure the power supply voltage to determine if it is in an acceptabletolerance. In certain embodiments, the predetermined criterion may be adigital or coded threshold range used to define the proper operatingrange, whereby, the measured functional test output can be compared tothe criterion threshold (e.g., above or below) or compared to thecriterion range (e.g., within or outside) to determine functional teststatus of the component.

Returning to FIG. 4, the first device 402 compares the data related tothe functionality of the second device 404 with the list including theat least one predetermined criterion (420) to determine if the seconddevice 404 is functioning properly (422). In certain embodiments, thefirst device 402 annunciates or otherwise communicates an alarm to alerta user if it is determined that the second device 404 is not functioningproperly (424). The alarm may be at least one of an audio alarm, avibratory alarm, and a visual alarm.

In certain embodiments, the first device 402 does not have to poll thesecond device 404 to perform the functionality check if the seconddevice 404 automatically performs the functionality check atpredetermined intervals and automatically sends a signal or data relatedto the functionality of the second device 404 to the first device 402.In this manner, in certain embodiments, if the first device 402 does notautomatically receive a signal or data related to the functionality ofthe second device 404 within a predetermined time period, then the firstdevice 402 will annunciate an alarm to alert the user that the seconddevice 404 is not functioning properly.

FIG. 5 is a flow diagram illustrating steps in an embodiment formitigating single point failure of at least one device in an analytemonitoring system 500. The first device 502 and the second device 504 inthe analyte monitoring system 500 can be at least one of a receiverdevice, an analyte meter, a glucose monitor, an insulin pump, acontinuous analyte monitor, a cellular phone, a personal digitalassistant, a personal computer, a laptop computer, and/or a repeaterunit. Execution of the method begins at process block (506) when a firstdevice 502 sends a request that a functionality check of the componentsof a second device 504 be performed. The request can be sent, forexample, wirelessly from the transmitter of the first device 502 to thetransceiver of the second device 504. The components of the seconddevice 504 include at least one of a microprocessor, a power supply, asensor, an electronic component, and a storage device.

Referring to FIG. 5, the second device 504 receives the request toperform a functionality check from the first device 502 (508) and thesecond device 504 performs the functionality check of its components(510). In certain embodiments, the second device 504 only performs thefunctionality check if the second device 504 has the capacity to performthe check. The functionality check of the components can include adetermination of the current, voltage, and/or resistance that can bemeasured across an electrical circuit in the components. Additionally,the functionality check can include component testing that applies aninput to the various components being tested, and receives an outputbased on the input. The functionality check may also include checkingdigital system components, such as a checksum for a block of memory. Anyof a number of common techniques used in electronic devices can beapplied to this invention. In addition, some components of the devicesin the analyte monitoring system may have built in self-testfunctionality that can be queried, for instance, a power supply modulemay have a digital self-test status output that can be queried by theprocessor in order to determine the functionality of the power supply.Also, a device may have electronic circuitry that includes electronic ormechanical switches that allow testing of the electronic circuitry. Theswitch, for example, could route the current path for functional testacross the speaker circuit to test for the proper speaker resistance, inorder to detect any open or short circuits.

Referring back to FIG. 5, the second device 504 determines thefunctionality of its components based on the outcome of thefunctionality check (512) and communicates data related to thedetermined functionality of its components to the first device 502(514). The data can be communicated, for example, from the transmitterof the second device 504 to the transceiver of the first device 502. Incertain embodiments, the second device 504 may communicate data relatedto the functionality of its components to the first device 502 withoutdetermining the functionality of the components at the second device 504itself. The data related to the functionality of the components of thesecond device 504 is then received at the first device 502 (516) and thefirst device 502 retrieves from storage a list that includes at leastone predetermined criterion related to the functionality of thecomponents of the second device 504 (518). The predetermined criterioncan be, for instance, current, voltage and/or resistance thresholds orranges used to define the proper operating range. In certainembodiments, the functional check may measure the power supply voltageto determine if it is in an acceptable tolerance. In certainembodiments, the predetermined criterion may be a digital or codedthreshold range used to define the proper operating range. The measuredfunctional test output can be compared to the criterion threshold (e.g.,above or below) or compared to the criterion range (e.g., within oroutside) to determine functional test status of the component.

Referring still to FIG. 5, the first device 502 compares the datarelated to the functionality of the second device 504 with the listincluding the at least one predetermined criterion at process block(520) and determines if the second device 504 is functioning properly(522). If it is determined that the second device 504 is not functioningproperly, the first device 502 requests that the second device 504annunciate an alarm to alert a user that the second device 504 is notfunctioning properly (524). The request may be sent from the transmitterof the first device 502 to the transceiver of the second device 504. Thesecond device 504 receives the request from the first device 502 toannunciate the alarm to alert the user of its lack of properfunctionality (526) and then annunciates the corresponding alarm (528).The alarm may be at least one of an audio alarm, a vibratory alarm, anda visual alarm.

FIG. 6 is a flow diagram illustrating steps in one embodiment formitigating single point failure of at least one device in an analytemonitoring system 600 that includes a first device 602, a repeater unit604, and a second device 606. The first device 602 can include at leastone of a receiver unit, an analyte meter, a cellular phone, a personaldigital assistant, a personal computer, a laptop computer, and aninsulin pump. The repeater unit 604 can be operatively or physicallycoupled to second device 606. The second device can be an analyte sensorand/or a continuous glucose monitor.

Referring to FIG. 6, in certain embodiments, the first device 602 sendsa request to the repeater unit 604 that the second device 606 perform afunctionality check of its components (608). The request can be sent,for example, wirelessly from the transmitter of the first device 602 tothe transceiver of the repeater unit 604. The repeater unit 604 receivesthe request from the first device 602 (610) and sends, to the seconddevice 606, a request to perform a functionality check of the componentsof the second device 606 (612). The request may be sent, for example,wirelessly from the transmitter of the repeater unit 604 to thetransceiver of the second device 606.

Still referring to FIG. 6, the request to perform a functionality checkof its components is received at the second device 606 (614) and, if itis functioning in a high enough capacity, the second device 606 performsthe functionality check of one or more of its components (616). Incertain embodiments, the functionality check of the components caninclude a determination of the current, voltage, and/or resistance thatcan be measured across an electrical circuit in the one or morecomponents. Additionally, the functionality check can include componenttesting that applies an input to the various components being tested,and receives an output based on the input. The functionality check mayalso include checking digital system components, such as a checksum fora block of memory. Any of a number of common techniques used inelectronic devices can be applied to this invention. In addition, somecomponents of the devices in the analyte monitoring system may havebuilt in self-test functionality that can be queried, for instance, apower supply module may have a digital self-test status output that canbe queried by the processor in order to determine the functionality ofthe power supply. Also, a device may have electronic circuitry thatincludes electronic or mechanical switches that allow testing of theelectronic circuitry. The switch, for example, could route the currentpath for functional test across the speaker circuit to test for theproper speaker resistance, in order to detect any open or shortcircuits.

Returning to FIG. 6, the second device 606 determines the functionalitycheck of its components based upon the results of the functionalitycheck (618) and data related to the results of the functionality checkare then communicated from the second device 606 to the repeater unit604 (620). The data can be communicated, for example, wirelessly fromthe transmitter of the second device 606 to the transceiver of therepeater unit 604. The repeater unit 604 receives the data related tothe results of the functionality check of the one or more components ofthe second device 606 (622) and communicates the data related to theresults of the functionality check of the second device 606 to the firstdevice 602 (624). The data can be communicated, for example, wirelesslyfrom the transmitter of the repeater unit 604 to the transceiver of thefirst device 602. The data related to the functionality check of the oneor more components of the second device 606 is then received at thefirst device 602 (626). The first device 602 retrieves from storage alist including at least one predetermined criterion related to thefunctionality of the one or more components of the second device (628)and compares the data related to the results of the functionality checkwith the list including the at least one predetermined criterion (630).The predetermined criterion can be, for instance, current, voltageand/or resistance thresholds or ranges used to define the properoperating range. For instance, the functional check may measure thepower supply voltage to determine if it is in an acceptable tolerance.Additionally, the predetermined criterion may be a digital or codedthreshold range used to define the proper operating range. The measuredfunctional test output can be compared to the criterion threshold (e.g.,above or below) or compared to the criterion range (e.g., within oroutside) to determine functional test status of the component. The firstdevice 602 then determines if the second device 604 is functioning inaccordance with the at least one predetermined criterion (632) and, ifit is determined that the second device 606 is not functioning inaccordance with the at least one predetermined criterion, requests thatthe repeater unit 604 annunciate an alarm (634). The request can besent, for example, from the transmitter of the first device 602 to thetransceiver of the repeater unit 604. The repeater unit 604 receives therequest from the first device 602 to annunciate an alarm to alert a userthat the second device 606 is not functioning properly (636) andaccordingly an alarm is annunciated by the repeater unit 604 (638). Thealarm may include at least one of an audio alarm, a vibratory alarm, anda visual alarm that is produced at the repeater unit 604.

In certain embodiments, the first device 602 does not have to send arequest to the repeater unit 604 if the repeater unit 604 automaticallypolls the second device 606 to perform the functionality check or if thesecond device 606 automatically performs the functionality check atpredetermined intervals and then automatically sends this information tothe repeater unit 604. In this instance, if the repeater unit 604 doesnot receive a signal or data related to the functionality of the seconddevice 606, then the repeater unit 604 can annunciate an alarm to alertthe user that the second device 606 is not functioning properly.

FIG. 7 is a flow diagram illustrating an embodiment for mitigatingsingle point failure of the transmitter of at least one device in ananalyte monitoring system 700 that includes a first device 702 and asecond device 704. The first device 702 sends a request to a seconddevice 704 to perform a functionality check of the components of thesecond device 704 (706). If a signal or data has not been received atthe first device 702 within a predetermined amount of time, then thefirst device 702 determines that at least one of the components of thesecond device 704 is not functioning properly (710) and annunciates analarm to alert a user that the second device 704 is not functioningproperly (712).

In certain embodiments, the first device 702 does not have to requestthat the second device 704 perform a functionality check of itscomponents, as the second device 704 automatically performs thefunctionality check at predetermined intervals and then automaticallysends data related to the results of the functionality check to thefirst device 702. In this instance, if the first device 702 does notautomatically receive data related to the functionality of the seconddevice 704, then the first device 702 determines that the second device704 is not functioning properly and annunciates an alarm at the firstdevice 702 to alert the user.

In certain embodiments, the analyte monitoring system includes at leastone transmitter attached to the continuous analyte sensor, the receiverdevice, and the insulin pump. In certain embodiments, the receiverdevice and/or the insulin pump will detect if the transmitter in thecontinuous analyte sensor stops functioning. In certain embodiments, theinsulin pump and/or the continuous analyte sensor will detect if thetransmitter in the receiver device stops functioning. In certainembodiments, the receiver device and/or the continuous analyte sensorwill detect if the transmitter in the insulin pump stops functioning.

In certain embodiments, a computer-implemented method for mitigatingsingle point failure of at least one device in an analyte monitoringsystem includes requesting that a functionality check of one or morecomponents of a first device be performed and that data related to thefunctionality check of the one or more components of the first device becommunicated to a second device, receiving information from the firstdevice that is related to functionality of the one or more components ofthe first device, communicating the information related to thefunctionality of the one or more components of the first device to athird device, receiving a request from the third device that an alarm beannunciated if it is determined by the third device that the one or morecomponents of the first device is not functioning in accordance with atleast one predetermined criterion, and annunciating an alarm to alert auser that the one or more components of the first device is notfunctioning in accordance with the at least one predetermined criterion.

In certain aspects, the first device is a continuous glucose monitor.

In certain aspects, the second device includes a repeater unitoperatively coupled to the continuous glucose monitor.

In certain aspects, the third device includes one of a receiver deviceor an insulin pump.

In certain aspects, the one or more components of the first deviceinclude at least one of a microprocessor, a power supply, a sensor, andan electronic component.

In certain aspects, the alarm includes at least one of an audio alarm, avibratory alarm, and a visual alarm.

Certain aspects include receiving a request from the third device that afunctionality check of one or more components of a first device beperformed and that data related to the functionality check of the one ormore components of the first device be communicated to the third device,wherein the request is received at the second device, the second devicebeing operatively coupled to the first device.

In certain aspects, the information related to the functionality of theone or more components of the first device includes a lack of data beingreceived from the first device.

Certain aspects include that the functionality check includes at leastone of a determination of a current, a voltage, and a resistance that ismeasured across an electrical circuit in the one or more components,applying an input to the one or more components and receiving an outputfrom the one or more components, a digital check of the one or morecomponents, a checksum of a memory of the first device, a self-testoutput check of the one or more components, and an electrical ormechanical test of at least one switch of the one or more components.

Certain embodiments include the at least one predetermined criterionincluding at least one of a current, a voltage, and a resistancethreshold used to define a proper operating range of the first device, apower supply measurement that defines an acceptable tolerance, and adigital threshold range used to define a proper operating range.

In certain embodiments, a computer-implemented method for mitigatingsingle point failure of at least one device in an analyte monitoringsystem includes requesting that a functionality check of one or morecomponents of a first device be performed and that data related to thefunctionality check of the one or more components of the first device becommunicated to a second device, receiving the data related to thefunctionality of the one or more components of the first device,retrieving a list including at least one predetermined criterion relatedto the functionality of the one or more components of the first devicefrom a storage component of the second device, comparing the datarelated to the functionality of the one or more components of the firstdevice with the list including the at least one predetermined criterion,and determining if the one or more components of the first device isfunctioning in accordance with the at least one predetermined criterion.

Certain aspects include requesting that an alarm be annunciated at athird device to alert a user if it is determined by the second devicethat the one or more components of the first device is not functioningin accordance with the at least one predetermined criterion.

In certain aspects, the third device is operatively coupled to the firstdevice.

In certain aspects, the request for the functionality check is receivedby a third device and the third device polls the first device to performthe functionality check.

Certain aspects include annunciating an alarm operatively coupled to thesecond device to alert a user if it is determined that the one or morecomponents of the first device is not functioning in accordance with theat least one predetermined criterion.

In certain aspects, the first device is a continuous glucose monitor.

In certain aspects, the second device is one of a receiver device or aninsulin pump.

In certain aspects, the third device is a repeater unit operativelycoupled to the continuous glucose monitor.

In certain aspects, the one or more first components of the first deviceinclude at least one of a microprocessor, a power supply, a sensor, andan electric component.

In certain aspects, the alarm includes at least one of an audio alarm, avibratory alarm, and a visual alarm.

Certain aspects include that the functionality check includes at leastone of a determination of a current, a voltage, and a resistance that ismeasured across an electrical circuit in the one or more components,applying an input to the one or more components and receiving an outputfrom the one or more components, a digital check of the one or morecomponents, a checksum of a memory of the first device, a self-testoutput check of the one or more components, and an electrical ormechanical test of at least one switch of the one or more components.

Certain aspects include that the at least one predetermined criterionincludes at least one of a current, a voltage, and a resistancethreshold used to define a proper operating range of the first device, apower supply measurement that defines an acceptable tolerance, and adigital threshold range used to define a proper operating range.

In certain embodiments, a computer-implemented method for mitigatingsingle point failure of at least one device in an analyte monitoringsystem includes requesting that a functionality check of one or morecomponents of a first device be performed and that data related to thefunctionality check of the one or more components of the first device becommunicated to a second device, and determining that the one or morecomponents of the first device is not functioning properly if the datarelated to the functionality check of the components of the first deviceis not received at the second device, wherein an alarm is annunciatedfrom at least one of the second device or a third device to alert a userthat one or more components of the first device is not functioningproperly.

Various other modifications and alterations in the structure and methodof operation of the embodiments of the present disclosure will beapparent to those skilled in the art without departing from the scopeand spirit of the present disclosure. Although the present disclosurehas been described in connection with certain embodiments, it should beunderstood that the present disclosure as claimed should not be undulylimited to such embodiments. It is intended that the following claimsdefine the scope of the present disclosure and that structures andmethods within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A computer-implemented method for mitigatingsingle point failure of at least one device in an analyte monitoringsystem, comprising: providing a request, from a first device to a seconddevice, that a functionality check of one or more components of a thirddevice be performed, wherein the functionality check includescommunicating, from the third device to the second device, data relatedto results of the functionality check; receiving, at the first device,the data related to the results of the functionality check from thesecond device; determining, by the first device, that the one or morecomponents of the third device is not functioning in accordance with atleast one predetermined criterion; and providing, to the second device,a request from the first device that an alarm function be initiated toalert a user that the one or more components of the third device is notfunctioning in accordance with the at least one predetermined criterion.2. The method of claim 1, wherein the first device comprises one of areceiver device or an insulin pump.
 3. The method of claim 1, whereinthe second device is a repeater.
 4. The method of claim 1, wherein thethird device is a continuous glucose monitor.
 5. The method of claim 1,wherein the request from the first device to the second device isprovided over a RF communication link.
 6. The method of claim 1, whereinthe data related to the results of the functionality check includes alack of data being received from the third device.
 7. The method ofclaim 1, wherein the data related to the results of the functionalitycheck include at least one of a determination of a current, a voltage,and a resistance that is measured across an electrical circuit in theone or more components, applying an input to the one or more componentsand receiving an output from the one or more components, a digital checkof the one or more components, a checksum of a memory of the firstdevice, a self-test output check of the one or more components, and anelectrical or mechanical test of at least one switch of the one or morecomponents.
 8. The method of claim 1, wherein the at least onepredetermined criterion includes at least one of a current, a voltage,and a resistance threshold used to define a proper operating range ofthe first device, a power supply measurement that defines an acceptabletolerance, and a digital threshold range used to define a properoperating range.
 9. The method of claim 1, further comprising initiatingan alarm of the first device to alert the user that the one or morecomponents of the third device is not functioning in accordance with theat least one predetermined criterion.
 10. The method of claim 1, whereinthe third device comprises an analyte sensor including a plurality ofelectrodes, wherein the plurality of electrodes include a workingelectrode comprising an analyte-responsive enzyme and a mediator,wherein at least one of the analyte-responsive enzyme and the mediatoris chemically bonded to a polymer disposed on the working electrode, andwherein at least one of the analyte-responsive enzyme and the mediatoris crosslinked with the polymer.
 11. An apparatus, comprising: acommunication interface; one or more processors; and a memory coupled tothe one or more processors, the memory storing instructions which, whenexecuted by the one or more processors, causes the one or moreprocessors to: provide a request to a second device, using thecommunication interface, that a functionality check of one or morecomponents of a third device be performed, wherein the functionalitycheck includes communicating, from the third device to the seconddevice, data related to results of the functionality check; receive,using the communication interface, the data related to the results ofthe functionality check from the second device; determine that the oneor more components of the third device is not functioning in accordancewith at least one predetermined criterion; and provide, to the seconddevice using the communication interface, a request that an alarmfunction be initiated to alert a user that the one or more components ofthe third device is not functioning in accordance with the at least onepredetermined criterion.
 12. The apparatus of claim 11, furthercomprising an insulin pump.
 13. The apparatus of claim 11, wherein thesecond device is a repeater.
 14. The apparatus of claim 11, wherein thethird device is a continuous glucose monitor.
 15. The apparatus of claim11, wherein the communication interface is a RF communication interface.16. The apparatus of claim 11, wherein the data related to the resultsof the functionality check includes a lack of data being received fromthe third device.
 17. The apparatus of claim 11, wherein the datarelated to the results of the functionality check include at least oneof a determination of a current, a voltage, and a resistance that ismeasured across an electrical circuit in the one or more components,applying an input to the one or more components and receiving an outputfrom the one or more components, a digital check of the one or morecomponents, a checksum of the memory of the apparatus, a self-testoutput check of the one or more components, and an electrical ormechanical test of at least one switch of the one or more components.18. The apparatus of claim 11, wherein the at least one predeterminedcriterion includes at least one of a current, a voltage, and aresistance threshold used to define a proper operating range of theapparatus, a power supply measurement that defines an acceptabletolerance, and a digital threshold range used to define a properoperating range.
 19. The apparatus of claim 11, further comprising analarm coupled to the one or more processors, and wherein the memorystoring instructions which, when executed by the one or more processors,causes the one or more processors to initiate the alarm coupled to theone or more processors to alert the user that the one or more componentsof the third device is not functioning in accordance with the at leastone predetermined criterion.
 20. The apparatus of claim 11, wherein thethird device comprises an analyte sensor including a plurality ofelectrodes, wherein the plurality of electrodes include a workingelectrode comprising an analyte-responsive enzyme and a mediator,wherein at least one of the analyte-responsive enzyme and the mediatoris chemically bonded to a polymer disposed on the working electrode, andwherein at least one of the analyte-responsive enzyme and the mediatoris crosslinked with the polymer.